FDA.reportPublic FDA data

Airtraq

Primary DI
08436031030617
Brand
Airtraq
Company
PRODOL MEDITEC, SA
Model
A-061
Device description
Airtraq SP Adult Nasal
Published
2023-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38436031030618PackageGS130In Commercial Distribution
48436031030615PackageGS12In Commercial Distribution
08436031030617PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3843603103061838436031030618
4843603103061548436031030615
08436031030617084360310306178436031030617

GMDN Terms#

Term, Definition table
TermDefinition
Channelled video intubation laryngoscopeA hand-held device intended to enable clear view of the trachea via video imaging to facilitate positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation, passing the ET tube through an integrated ET tube channel guide without use of a stylet for positioning. It typically consists of a body with an ET tube channel, an anatomically-shaped blade, and integrated electronic illumination and a video camera at the distal end; images are transmitted to an off-the-shelf device (e.g., tablet, smartphone, computer). This is a single-use device.

Regulatory Flags#

DUNS number
541001090
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436031030112AirtraqA-0112023-08-01
08436031030211AirtraqA-0212023-08-01
08436031030310AirtraqA-0312023-08-01
08436031030419AirtraqA-0412023-08-01
08436031030518AirtraqA-0512023-08-01
08436031033908AirtraqA-3902023-08-01
08436031033922AirtraqA-390-KIT2023-08-01
08436031035018AirtraqA-5012023-08-01
08436031035117AirtraqA-5112023-08-01
08436031035216AirtraqA-5212023-08-01
08436031035902AirtraqA-5902023-08-01
48436031030110AirtraqA-0112023-08-01
48436031030219AirtraqA-0212023-08-01
48436031030318AirtraqA-0312023-08-01
48436031030417AirtraqA-0412023-08-01
48436031030516AirtraqA-0512023-08-01
48436031030615AirtraqA-0612023-08-01
08436031030716AirtraqA-0712023-08-01
78436031033907AirtraqA-3902023-08-01
78436031033921AirtraqA-390-KIT2023-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
G14140464270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-05
G1414046400Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464290Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046430Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464380Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G141404643850Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464390Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G1414046440Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464470Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464480Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140464490Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466170Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466270Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466280Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03
G14140466370Carnegie Surgical LLCCarnegie Surgical LLCCCW2023-04-03